MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL COBALT¿ HF CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTPB2D4

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Syncope/Fainting (4411)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: 3058 urinary stim ipg; 978b128 urinary stim lead implanted: (b)(6) 2020; 5076-52 lead; 419688 lead implanted: (b)(6) 2021 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported by the patient representative that the patient was out to lunch and passed out.  the patient representative caught the patient from falling into their food and wasn¿t very coherent.  the cardiac resynchronization therapy defibrillator (crt-d) remains in use.  no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was later reported that the patient symptoms were not confirmed to be related to product performance.The patient was seen remotely and no action was taken.

• Brand Name: COBALT¿ HF CRT-D MRI SURESCAN¿
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18951914
• MDR Text Key: 338265187
• Report Number: 9614453-2024-01128
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178215
• UDI-Public: 00763000178215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2022
• Device Model Number: DTPB2D4
• Device Catalogue Number: DTPB2D4
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2024
• Date Device Manufactured: 12/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 620BG25 HEART BAND.
• Patient Outcome(s): Life Threatening
• Patient Age: 87 YR
• Patient Sex: Male